NOTICE
ANSM - Updated on: 11/27/2020
Drug Name
SILICEA COMPLEX No. 11, sublingual tablet
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What is in this package insert?
1. What is SILICEA COMPLEX No. 11, sublingual tablet, and what is it used for?
2. What information should you know before taking SILICEA COMPLEX No. 11, sublingual tablet?
3. How should you take SILICEA COMPLEX No. 11, sublingual tablet?
4. What are the possible side effects?
5. How should SILICEA COMPLEX No. 11, sublingual tablet, be stored?
6. Package contents and other information.
1. WHAT IS SILICEA COMPLEX No. 11, sublingual tablet, AND WHAT IS IT USED FOR?
SILICEA COMPLEX No. 11, sublingual tablet is a homeopathic medicine traditionally used for acne, and as an adjunct to local treatments for itchy rashes that tend to become infected.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING SILICEA COMPLEX No. 11, sublingual tablet?
Never take SILICEA COMPLEX No. 11, sublingual tablet:
· in children under 6 years of age.
· if you are allergic to the active ingredients or any of the other ingredients in this medication, listed in Section 6.
Warnings and Precautions
Consult your doctor or pharmacist before taking SILICEA COMPLEX No. 11, sublingual tablet.
· This medicine is intended for adults and children over 6 years of age.
· If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.
· Due to the presence of the SILICEA strain in the formula, this medication should not be used for otitis or sinusitis without medical advice.
Children
Not applicable.
Other medications and SILICEA COMPLEX No. 11, sublingual tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
SILICEA COMPLEX No. 11, sublingual tablet with food and beverages
This medication should be taken between meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medication.
In the absence of experimental and clinical data, and as a precaution, the use of this medication should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Not applicable.
SILICEA COMPLEX No. 11, sublingual tablet contains lactose.
3. HOW TO TAKE SILICEA COMPLEX No. 11, sublingual tablet?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any doubts.
Dosage
· Adults and adolescents over 12 years of age: 2 tablets 2 to 3 times a day.
· Children over 6 years of age: 1 tablet 2 to 3 times a day.
Administration
Chewable tablet to be allowed to dissolve under the tongue, preferably between meals.
Sublingual route.
Duration of treatment
· Treatment of acne: the maximum duration of treatment is 3 months. If there is no improvement after 1 month, consult a doctor.
· Treatment of itchy rashes: the maximum duration of treatment is 1 month. If there is no improvement after 8 days, consult a doctor.
If you have taken more SILICEA COMPLEX No. 11 sublingual tablets than you should have
Consult your doctor or pharmacist immediately.
If you forget to take SILICEA COMPLEX No. 11, sublingual tablet
Do not take a double dose to make up for the dose you missed.
If you stop taking SILICEA COMPLEX No. 11, sublingual tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD SILICEA COMPLEX No. 11, sublingual tablet, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the packaging or blister pack. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SILICEA COMPLEX No. 11, sublingual tablet contains
· The active ingredients are:
Silicea 3 DH..................................................................................................................... 25 mg
Argentum metallicum 4 DH................................................................................................ 25 mg
Antimonium crudum 4 DH................................................................................................. 25 mg
Arsenicum album 6 DH..................................................................................................... 25 mg
Calcarea fluorica 4 DH...................................................................................................... 25 mg
Ferrum phosphoricum 3 DH.............................................................................................. 25 mg
Magnesia phosphorica 3 DH............................................................................................. 25 mg
Mercurius solubilis 8 DH................................................................................................... 25 mg
Manganum peroxydatum 3 DH.......................................................................................... 25 mg
per 250 mg sublingual tablet
· The other ingredients are: lactose, rice starch, magnesium stearate.
What is SILICEA COMPLEX No. 11, sublingual tablet, and contents of the outer packaging
SILICEA COMPLEX No. 11, sublingual tablet is a 250 mg sublingual tablet.
Box of 60 tablets packaged in 3 blister packs of 20 tablets (PVC/Aluminum).
Marketing Authorization Holder
LABORATOIRES LEHNING
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Marketing Authorization Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Manufacturer
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information on this medication is available on the ANSM (France) website.